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Engineering Manufacturing Lead

2 weeks ago


Fremont, California, United States Moximed Full time
Engineering Manufacturing Lead

We are seeking an experienced Engineering Manufacturing Lead to join our team at Moximed.

The successful candidate will be responsible for overseeing and improving medical device production processes, ensuring quality, cost-efficiency, and regulatory compliance.

Key Responsibilities:

  • Create or revise manufacturing process instructions and lot history records.
  • Design and implement fixtures and other manufacturing processing aids.
  • Provide engineering support and training to the manufacturing line.
  • Create and perform engineering validations and verifications on new and existing products or equipment.
  • Work with suppliers on the development of specifications and validation/qualification of processes.
  • Lead projects related to the improvement and/or development of manufacturing for scaling of production.
  • Support Regulatory and Operations in the sourcing, qualification, and implementation of new potential suppliers.
  • Work with Quality and suppliers to address nonconformances, CAPAs, and SCARs.
  • Support R&D in the development and implementation of product updates/enhancements.
  • Support cost-saving and product-improvement projects.
  • Analyze and plan workflow, equipment placement, and space requirements to improve manufacturing efficiency.
  • Develop KPIs and report manufacturing performance metrics.
  • Perform and document complaint investigations in conjunction with Quality.